The Effect of Dihydralazine on Kidney Function and Hormones in Healthy Individuals

This study has been completed.
Sponsor:
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00311974
First received: April 5, 2006
Last updated: February 17, 2010
Last verified: February 2010
  Purpose

We, the investigators at Holstebro Hospital, want to test the hypothesis that dihydralazine leads to the activation of the sympathetic nervous system in healthy individuals.


Condition Intervention Phase
Healthy
Drug: Dihydralazine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Official Title: The Effect of Dihydralazine on Renal Tubular Function and Vasoactive Hormones in Healthy Individuals

Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • Fractional sodium excretion
  • Heart rate
  • Blood pressure

Estimated Enrollment: 16
Study Start Date: April 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men
  2. Ages 18 to 40 years.
  3. Body mass index less than or equal to 30 kg/m2

Exclusion Criteria:

  1. History or clinical signs of heart, lung, kidney, or endocrine organ disease.
  2. Abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine, P-albumin, P-bilirubin, P-alanine aminotransferase, P-alkaline phosphatase, P-cholesterol, and B-glucose.
  3. Abnormal screening of the urine regarding: albumin and glucose
  4. Malignant disease.
  5. Known arterial hypertension or measured 24 hour blood pressure above 135 mmHg systolic or 85 mmHg diastolic.
  6. Alcohol abuse.
  7. Smoking.
  8. Drug use or abuse.
  9. Known intolerance or allergy to dihydralazine
  10. Blood donation within 1 month of the start of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311974

Locations
Denmark
Department of Medical Research, Holstebro Hospital
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Study Chair: Erling B Pedersen, Professor Department of Medical Research, Holstebro Hospital, Denmark
Principal Investigator: Henrik Vase, MD Department of Medical Research, Holstebro Hospital, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00311974     History of Changes
Other Study ID Numbers: MED.RES.HOS.2006.01.HV, 99127500
Study First Received: April 5, 2006
Last Updated: February 17, 2010
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Regional Hospital Holstebro:
Dihydralazine
Sympathetic activation
Fractional sodium excretion

Additional relevant MeSH terms:
Dihydralazine
Hormones
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014